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1. 哈尔滨工业大学(威海)数字化医疗装备山东省重点实验室,山东 威海,264209
2. 哈尔滨医科大学 附属三院检验科,黑龙江 哈尔滨,150040
纸质出版日期:2012-12-10,
收稿日期:2012-10-12,
修回日期:2012-10-26,
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赵建文, 陈艳宁, 路士州. 化学发光免疫检测仪涉及的关键技术[J]. 发光学报, 2012,33(12): 1381-1388
ZHAO Jian-wen, CHEN Yan-ning, LU Shi-zhou. Key Technologies of Chemiluminescence Immunoassay Analyzer[J]. Chinese Journal of Luminescence, 2012,33(12): 1381-1388
赵建文, 陈艳宁, 路士州. 化学发光免疫检测仪涉及的关键技术[J]. 发光学报, 2012,33(12): 1381-1388 DOI: 10.3788/fgxb20123312.1381.
ZHAO Jian-wen, CHEN Yan-ning, LU Shi-zhou. Key Technologies of Chemiluminescence Immunoassay Analyzer[J]. Chinese Journal of Luminescence, 2012,33(12): 1381-1388 DOI: 10.3788/fgxb20123312.1381.
为实现化学发光免疫检测方法的临床应用
在深入分析化学发光免疫检测过程的基础上
对其涉及的各项关键技术进行了研究。针对化学发光免疫检测过程的3个关键环节:加样、洗涤和测量
提炼出化学发光免疫检测仪涉及的3项关键技术:微量液体试样精确加样技术、免疫复合物充分无损分离技术、微弱闪光信号精确测量技术。在液体加样方面
通过微升级别液体加注过程的分析及仿真给出加样模块相关参数的优化原则;在免疫复合物分离方面
通过复合物颗粒磁分离过程的分析给出磁场设计原则;在光检方面
给出了测量室设计原则及光电信号数据处理原则。在攻克上述关键技术的基础上
研制出Autolumis 3000化学发光免疫分析仪并成功实现临床应用。测试结果表明
仪器的变异系数 (Coefficient of variance
CV)为5%
最大检测速度为每小时180次
达到国外同类高端仪器的水平
表明所研究的关键技术是可行的。
To apply the chemiluminescence immunoassay method in clinical applications
some key technologies were investigated based on deeply analyzing the chemiluminescence immunoassay process. Firstly
three key steps about the immunoassay were indicated: filling-up
washing and measuring. Accordingly
three key technologies were summarized: accurate filling-up of microcontent liquid
quick and effective separation of immune complex
and accurate measurement of weak optical signal. In the aspect of filling-up
based on the analysis and simulation of milliliter level liquid filling-up process
the principle for optimizing relative sampling parameter was obtained. In the aspect of washing
the principle for designing the magnetic field was then obtained based on the analysis of separating immune complex process. In the aspect of measuring
the principles for designing measuring room and processing optical signal were given. After investigating the above-mentioned key technologies
chemiluminescence immunoassay analyzer Autolumis 3000 has been developed and applied in hospital. The results show that the coefficient of variance (CV) is 5% and the maximum speed is 180 time/h. This analyzer can achieve similar performance comparing with the current high-end equipment in abroad
which validates our investigation of the key technologies.
化学发光免疫检测医疗仪器
chemiluminescenceimmunoassaymedical instrument
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